The New Middle Ground: Between RX & Over The Counter


SAN FRANCISCO (ASRN.ORG) -- If you were taking the NCLEX today, and were asked if there was a middle ground between prescription and OTC, would you answer "yes" or "no"? Well, get ready. The answer is a surprising yes. If you're a male nurse, you may not be aware that even right now, Plan B, Barrs's emergency contraception pill is sold this way now. It's called "behind the counter".

The FDA is looking to expand this "behind the counter" gray area, the middle ground between drugs that require a prescription and those that anyone can buy off the shelf, and said it is holding hearings in this largely uncharted territory next month to discuss the possibility of putting more medicines into this middle-world.

Under the plan the agency’s considering, behind the counter drugs might be available after a chat with a pharmacist, and without a prescription. An FDA official suggested the arrangement could work for drugs that have a low risk of serious side effects and treat conditions that can be diagnosed by the general public. The uninsured, in particular, might benefit from the system, he commented.

A panel of FDA advisers turned down Merck and Johnson & Johnson’s request to sell the cholesterol drug Mevacor over the counter in 2005 — but a majority of the panel said they would have approved it as a behind the counter drug.

Other countries including Australia, Canada, New Zealand and many European countries already have behind the counter systems. Such an approach could be a transitional step in this country for moving some drugs off controlled prescription status. The agency’s asking for input on whether that would be a good idea, and on what logistical hurdles might arise for pharmacies in implementing more behind the counter sales.

One advantage would be that a doctor's prescription wouldn't be required, a costly and sometimes prohibitive financial obstacle that keeps the uninsured from getting the appropriate medication. The AMA is likely to fight It, as it removes the necessity of their consultation.

So check back to find out which direction the FDA takes. In all probability, there will be an expansion for the behind the counter drugs, and remember to advise your students or close friends that this question may be on the NCLEX.


Articles in this issue:


  • Masthead

    Editor-in Chief:
    Kirsten Nicole

    Editorial Staff:
    Kirsten Nicole
    Stan Kenyon
    Robyn Bowman
    Kimberly McNabb
    Lisa Gordon
    Stephanie Robinson

    Kirsten Nicole
    Stan Kenyon
    Liz Di Bernardo
    Cris Lobato
    Elisa Howard
    Susan Cramer

Leave a Comment

Please keep in mind that all comments are moderated. Please do not use a spam keyword or a domain as your name, or else it will be deleted. Let's have a personal and meaningful conversation instead. Thanks for your comments!

Image Captcha